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China Medical Device Regulatory Strategy Report

China's medical device market, currently in a rapid state of expansion, is regulated by the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration or CFDA. All medical devices must receive NMPA approval before they can be marketed in the country, though Class I devices are subject to a simpler notification process.

Chinese medical device regulations requires local testing for all but the lowest-risk devices, regardless of whether tests have been performed elsewhere, for NMPA approval.

Eligibility for market clearance in China also requires a manufacturer to have prior approval in the device’s country of origin (or country of manufacture).

Let Emergo assist you in navigating medical device registration in China and the NMPA approval framework as it applies to your device(s).

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Within the UL family of companies, we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body, and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest, and protection of both our brand and our customers' brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn morehere.